An Evaluation of the Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET (Stress-Rest) Myocardial Perfusion Imaging (MYPERS)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean and standard deviation of coronary flow reserve (CFR)
研究概览
简要总结
There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients. They also want to test people who don't have SCD to see if their hearts react the same way under stress.
Primary Objective
- To estimate the coronary flow reserve (CFR) (also referred to as myocardial perfusion reserve), as measured by PET stress-rest myocardial perfusion imaging, in SCD patients with and without diastolic dysfunction, and healthy controls.
Secondary Objectives
- To investigate the relationship between decreased CFR (quantified with PET stress- rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
详细描述
This study requires two visits. The first visit includes blood tests, an electrocardiogram (EKG), and an echocardiogram. The second visit includes a positron emission tomography (PET) stress test and a blood test.
Subjects will be considered off-study one week after all post PET imaging study tests have been completed along with the next day and one-week follow-up phone calls are completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stratum A: Sickle cell patients with diastolic dysfunction
- •18 to 21 years of age
- •Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- •Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- •Inclusion Criteria - Stratum B: Sickle cell patients without diastolic dysfunction
- •18 to 21 years of age
- •Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
- •Two or less abnormal diastolic parameters
- •Inclusion Criteria - Stratum C: Healthy controls
- •18 to 21 years of age
- •Two or less abnormal diastolic parameters
排除标准
- •Stratum A:
- •Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- •Blood transfusion in the last 3 months
- •Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- •Individuals with history of VT/VF or SVT
- •Previous cardiac surgery
- •Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- •Stenotic valvular disease or left main coronary artery stenosis
- •History of myo/pericarditis
- •Left ventricle systolic dysfunction
- •Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- •History of sinus node dysfunction or high grade AV nodal block
- •History of aborted sudden cardiac death or cardiac arrest
- •Current seizure disorder on AED
- •Pregnant/Breast-feeding
- •Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
- •Exclusion Criteria - Stratum B:
- •Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- •Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
- •Blood transfusion in the last 3 months
- •Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- •Individuals with history of VT/VF or SVT
- •Previous cardiac surgery
- •Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- •Stenotic valvular disease or left main coronary artery stenosis
- •History of myo/pericarditis
- •Left ventricle systolic dysfunction
- •Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- •History of sinus node dysfunction or high-grade AV nodal block
- •History of aborted sudden cardiac death or cardiac arrest
- •Current seizure disorder on AED
- •Pregnant/Breast-feeding
- •Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
- •Exclusion Criteria - Stratum C:
- •All genotypes of SCD
- •Diagnosed with three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
- •Anemia of grade 2 or worse (per CTCAE v5.0) at study visit 1
- •Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
- •Individuals with history of VT/VF or SVT
- •Previous cardiac surgery
- •Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
- •Stenotic valvular disease or left main coronary artery stenosis
- •History of myo/pericarditis
- •Left ventricle systolic dysfunction
- •Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
- •History of sinus node dysfunction or high-grade AV nodal block
- •History of aborted sudden cardiac death or cardiac arrest
- •Current seizure disorder on AED
- •Pregnant/Breast- feeding
- •Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
研究组 & 干预措施
Stratum B
Sickle cell patients without diastolic dysfunction
干预措施: Positron emission tomography (Diagnostic Test)
Stratum A
Sickle Cell patients with diastolic dysfunction
干预措施: [13N]NH3 (Drug)
Stratum C
Healthy controls
干预措施: [13N]NH3 (Drug)
Stratum C
Healthy controls
干预措施: Positron emission tomography (Diagnostic Test)
Stratum A
Sickle Cell patients with diastolic dysfunction
干预措施: Positron emission tomography (Diagnostic Test)
Stratum B
Sickle cell patients without diastolic dysfunction
干预措施: [13N]NH3 (Drug)
Stratum A
Sickle Cell patients with diastolic dysfunction
干预措施: Lexiscan (Drug)
Stratum B
Sickle cell patients without diastolic dysfunction
干预措施: Lexiscan (Drug)
Stratum C
Healthy controls
干预措施: Lexiscan (Drug)
结局指标
主要结局
Mean and standard deviation of coronary flow reserve (CFR)
时间窗: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
We will estimate the mean and standard deviation of CFR, as measured by PET myocardial blood flow reserve imaging, in young adult SCD patients with and without diastolic dysfunction and healthy controls.
CFR difference among Stratum A, Stratum B, and Stratum C
时间窗: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
We will compare whether the CFR is different among 3 predefined strata: Stratum A; SCD with diastolic dysfunction patients , Stratum B; SCD without dysfunction patient control, and Stratum C; normal healthy controls by one-way ANOVA or Kruskal-Wallis one-way analysis of variance, depending on the distribution of the data. If the difference exists, the pairwise comparison will be carried out by two sample t test or Wilcoxon rank sum test between two strata.
次要结局
- Relationship between decreased CFR (quantified with PET stress-rest myocardial perfusion imaging) and presence of abnormal diastolic parameters(Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour))